Group Cognitive Behavioural Therapy for Paternal Perinatal Depression

NCT07166237 | Active Not Recruiting

• 1 other identifier: CBT for Paternal PND Pilot RCT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot randomized controlled trial is to assess the feasibility of offering a 9-week group cognitive behavioural therapy (CBT; a type of talking therapy) led by a psychiatrist and public health nurse to fathers and non-birthing parents who identify as fathers or fathers-to-be (have a partner who is expecting) with perinatal depression. Fathers or fathers-to-be living in Ontario who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.

Conditions

Perinatal Depression; Fathers

Keywords

cognitive behavioral therapy; paternal depression; perinatal depression; fathers

Outcome Measures

Primary Outcomes (4)

• Number of participants recruited in recruitment period

  Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months

  6 months

• Number of participants who complete all data collection procedures

  75% of participants complete all three questionnaires and structured interviews

  6 months

• Number of participants who complete study (retention)

  75% of participants remain in study until completion

  6 months

• Number of participants who complete the intervention (adherence)

  80% of participants in treatment group complete the intervention

  6 months

Secondary Outcomes (1)

• Estimate treatment effect - Edinburgh Postnatal Depression Scale (EPDS)

  9 weeks

Other Outcomes (22)

• Estimate treatment effect - Edinburgh Postnatal Depression Scale (EPDS)

  6 months

• Major Depressive Disorder

  9 weeks

• Major Depressive Disorder Module

  6 months

Study Arms (2)

9-Week Group Cognitive Behavioural Therapy Intervention

EXPERIMENTAL

The experimental group will receive a 9-week group CBT intervention delivered by a psychiatrist and a public health nurse in addition to receiving treatment as usual.

Behavioral: Cognitive Behavioral Therapy for Paternal Perinatal Depression

Control/Usual Care

NO INTERVENTION

Participants randomized to the No Intervention group will continue to receive treatment as usual (standard care). A list of resources will be emailed.

Interventions

Cognitive Behavioral Therapy for Paternal Perinatal Depression BEHAVIORAL

Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The weekly group sessions will be two hours long and take place once a week for 9 consecutive weeks. The first hour of the session will involve teaching and practice of CBT skills, followed by one hour of unstructured discussion around topics relevant to participants with paternal perinatal depression. Each group will be delivered online via Zoom and guided by our intervention manual.

9-Week Group Cognitive Behavioural Therapy Intervention

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers with an infant \<18 months at recruitment, be fluent in written/spoken English, have an EPDS score ≥9 and live in Ontario

You may not qualify if:

• Free of bipolar, psychotic, borderline personality and current substance use disorders

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A parallel-group Ontario-wide RCT with experimental (9-week CBT + TAU) and control (TAU) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control groups.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)